Price controls for physician services, the results are predictable

In the September 28, 2006 edition of DB's Medical Rants we find a great quote from Scapel entitled "Are all physicians equal?"

In one of the subsequent letters to Scapel we are correctly told that in the health care "market" prices are determined by a fairly small number of payers, e.g. CMS and the major insurers who follow CMS lead. In regard to physician's fees, there is -for the most part- price controls.Since insurers tend to duplicate CMS's fee structures we have in effect government price controls on physician fees.
(I realize there are a small minority of physicians who operate outside of this control system, for example some dermatologists who do mainly cosmetic work and the concierge practices)

I wrote about this issue before when I suggested an important addition to the medical school curriculum, namely a primer on basic real world economics.What happens when there are price controls is well recognized and repeatedly has been explained in great clarity by economists such as Thomas Sowell.Here are some of his comments on that subject.

Four things tend to happen when there are price controls:

1.Demand increases,there is increased use of the service or product (A recent example-see how long it takes to get in for a colonoscopy since Medicare began covering screening exams)

2.Supply decreases and shortages develop(with price controls in place, suppliers do not rush into that market and we are seeing that in the area of primary care, where fees are set the lowest, fewer medical graduates are opting for primary care specialties)

3.Quality decreases.(providers have little reason to try and differentiate themselves on the basis of quality because of 1 and 2 they have no need for new customers.They may try and make up for lower unit prices by increasing their volume of business, spending less time with each customer, etc.)

4.Black markets tend to develop.This apparently has not happened yet here but has in rigidly socialized countries.

To quote Sowell (from Applied Economics,Thinking Beyond Stage One,2004,Basic Books, p.93)

"All of these things have been found when the prices of medical care have been controlled-and all are particularly harmful in matters involving, pain ,disability and death".

The DREAM study, Are we preventing or just delaying diabetes?

The results of the DREAM study have published in the NEJM (ramipril arm) and the Lancet ( rosiglitizone arm) . This trial will get a lot of press and in the eyes of cynical old docs like me a lot of spin. Fortunately, the eagle eyed and clear thinking world of medical bloging will have offer anti-spin or at the least an opinion a bit different from the pharm company's press releases ( see here and here ) and the repetition of some of it by main stream media .

DREAM was large randomized clinical trial involving patients with the label pre-diabetes ( impaired fasting glusoce and/or glucose intolerance) and the aim was to see if a TZD (thiazolidenedione) and/or an ace inhibitor would prevent the progression of pre diabetes to diabetes. The rosi group received daily rosiglitizone for 3 years plus education regarding diet and exercise and 11.6 % progressed to diabetes in 3 years versus 26% of the placebo group.In the rosi group 0.5% developed heart failure versus 0.1% in the placebo group.The ramipril trial was negative in the sense of no effect on the development of diabetes.

Here is how the study's authors framed things in the final paragraph of their discussion section-paraphrased- If you treat 1000 patients for three years with rosiglitizone, 144 cases of diabetes will be prevented and 5 will develop heart failure.

The problem I have with that is the use of the word "prevented". I take prevent to mean you will not develop a condition. In this situation I believe you are simply delaying what seems to be almost always the case in type 2 diabetes-and by extension pre-diabetes- progressive worsening of the glucose control. Here prevention seems to mean to "prevent" diabetes for three years. The data is just not sufficient to make the statement that diabetes has been prevented.To be able to say that you would need a really long follow up.

It is well known that TZDs can improve blood sugar control in diabetes and it is no surprise it could do the same in patients with early diabetes -or pre-diabetes-and it is also well known that they may cause fluid retention and heart failure. so I see nothing really new here except what I think is exaggerated talk about prevention.

The comments made after the Diabetes Prevention Trial( o.k., they called it prevention)were much more appropriately circumspect. That trial compared exercise plus diet, metformin and a control group all with glucose intolerance and over a 3 year period 29% of the control group , 22% of the metformin group and 14% of the exercise/diet group developed diabetes."We simply don't know how long beyond the 3 year period diabetes can be delayed " was the comment made by one of the study's authors. This is a study whose results I frequently discussed with overweight patient with borderline blood sugars in the hope of encouraging life style changes but I did not promise diabetes would be prevented.

NIH report on use of multi-vitamins-we just don't know

The September 5, 2006 issue of the Annals of Internal Medicine reports on a NIH Conference on the use of multivitamins/mineral supplements (MVMs) and chronic disease prevention.

Their conclusion:

...the present evidence is insufficient to recommend either for or against the use of MVMs by the American public to prevent chronic disease."

A major reason for the panel's inability to make a firm recommendation is the lack of randomized clinical trials.However, the panel interestingly also states that "multivitamin trials are unlikely to lead to generalizable knowledge".

This is because a distinction between the effects of the individual components is unlikely to be made for several reasons including 1)the placebo group is likely to take vitamins anyway, 2)a very large sample size would be required making funding and execution of the trial problematic and 3)results would be likely outdated as the composition of the commonly used MVMs tend to change. Further, there is reason to believe that some subgroups may benefit from a given component while another subgroup might be harmed.

So what are we hearing? We cannot say if MVMs should be taken by everyone to prevent chronic disease or cancer because of the lack of RCTs and it is unlikely that even if we could the related RCTs they probably would not answer the question anyway. Should we withhold judgment if there is no randomized trial directly addressing the issue? Are we unnecessarily limiting ourselves by punting every question if RCTs are not available? That does appear to be the modus operandi of the public health community and yet in that context there is justification for withholding judgment until the evidence is quite strong. To make policy decisions sound evidence is required. Individual physicians have to often make decisions with the data they have not the evidence they wished they had. Of course, physicians do not have to tell everyone what to do , just the patient on the other side of the desk.

From the Annals of Internal Medicine:Oscar winners live longer-no,wait, maybe they don't

The September 2006 issue of the Annals of Internal Medicine published an article (Do Oscar Winners Live Longer than less Successful Peers? A reanalysis of the evidence.Sylvestre,Huszti,and Hanley.Annals Internal Medicine,vol.145, no. 5, p. 361) that contradicted an earlier Annals'article that claimed Oscar winners live longer than their fellow actors.The abstract is available online. Why does a respected medical journal bother itself with this issue anyway?

Subscription is required for the full text of the article and also for the important letter from two of the Annals editors, Steven Goodman, an epidemiologist whose work I have found very impressive and useful and Harold Sox the editor. The original paper was published 5 years ago and found-by one analysis-a 3.9 year increase in life expectancy in Oscar winners. Here the operative words appear to be "by one analysis". The results vary significantly based on the type of analysis used and the epidemiologists-statisticians are not in agreement on how to analyse the data.

The issue here, as explained by Goodman and Sox is "when to start the clock" in a situation wherein there is a sudden change in risk due some event. Such events could include starting a treatment and in that instance there would be considerable medical interest, certaintly more than Oscar winner' longevity. Starting the clock at the wrong time can trigger something called "the immortal time bias" ( also known as "time zero" problem) something I have posted about before in the context of COPD treatment.

One study demonstrated that inhaled corticosteroids (ICS) treatment increased survival in COPD but another analysis indicated that the survival advantage was not real but an example of the immortal time bias although the original authors denied that was the case. Just as in the Oscar winner longevity controversy there was disagreement if there was or was not a bias in the ICS data due to disagreements about the clock starting issue.

The Annals editorialists state their explanatory comments are published largely because "the analytic methods at issue apply to many health care research questions ."Apparently the statistical issue of how to handle the zero time issue is not settled as Goodman and Sox invite other members of the statistical fraternity to "take up the challenge of determining the most appropriate way to measure the effect of winning an Oscar and the statistical uncertainty around the results." Of course, their concern is not really with Oscar winners's longevity but with the application of these techniques to more therapeutically relevant medical studies.

How to analyze the evidence in evidence based medicine is still to a large degree a work in progress.

No pens or mugs allowed from Big Pharma at Stanford

It has not gone unnoticed (whatever does) by the medical blogger world the irony or hypocrisy of Stanford's Medical School prohibiting the receipt of drug companies' pens and mugs (which are recognized to contain tiny and incredibly powerful mind-control devices) but continuing to allow faculty to be involved in numerous financial arrangements with drug and other medically related business entities. Free lunches and drug samples are also prohibited in their new policy but apparently faculty members can sit on boards of directors of drug and other medical businesses.

Multiple examples of the multiple conflicts of interests at Stanford was highlighted by Health Care Renewal 's Sept 14,2008 posting. No mention is made in the Stanford game plan to do away with the lucrative arrangements between faculty members Big Pharma and other medically related commercial enterprises. Standford's Dean Pizzo's video explaining the new policy can be found on their web site.

FDA offers recipe for proper mixing of aspirin and ibuprofen

Aspirin is widely used to decrease the risk of heart attacks. It is an essential part of secondary prophylaxis and typically is recommended to persons who have not had a cardiac event but who have an increased risk of developing coronary artery disease. The American Heart Association recommends prophylactic aspirin for those who have a ten year heart attack risk of 10% or greater and the usually-much-more conservative U.S Preventive Services Task Force recommends aspirin for those who have a five year risk of 3 % or higher.

Ibuprofen is widely used for a variety of aches and pains and its use is prevalent in the same age group who usually qualify for aspirin prophylaxis. However, there is evidence that ibuprofen may interfere with the beneficial effect that aspirin has on blood platelets. It is thought that ibuprofen and perhaps other NSAIDs interfere with aspirin gaining access to the molecular site on which it acts to inhibit platelet aggregation which is the putative mechanism involving in aspirin's success in decreasing coronary events.( Ibuprofen and aspirin are thought to chemically link up to sites in close proximity so that ibuprofen's presence may "crowd out" aspirin)

The FDA has recently published a paper explaining what is known about the asa-ibuprofen interaction issue and what practically can be done to enjoy whatever cardioprotective effect aspirin has and still be able to take ibuprofen for various pains. It is well worth reading and perhaps having copies handy to give patients.

Basically the advice is this:

Wait at least 1/2 hour after taking immediate release aspirin before taking ibuprofen. Wait 8 hours after taking 400 mg. of ibuprofen before taking aspirin.

The above advice does not apply to the popular enteric coated aspirin (ECASA) whose absorption is slower and 1/2 hour may not be long enough for aspirin to complete its inhibition of cyclooxygenase.The FDA did not believe there was adequate evidence to make specific recommendations regarding other NSAIDs-other than a general cautionary note. However, one recent article provided some data indicating a similar problem with the combination of aspirin and naproxen.

Should the single digital FOBT be abandoned?

For years physicians in the office setting have included a digital rectal exam and then tested stool captured by the gloved finger for occult blood.

A recent study published in the Annals of Internal Medicine compared the results of the single digital FOBT ( fecal occult blood test) with the take home FOBT kit which involves the patient testing 6 samples of stool at home presumably after following the dietary guidelines indicated in the literature found with the kit. 6 samples should be better than 1 in terms of sensitivity which is exactly what the researchers found in 2655 patients who also underwent screening colonoscopy.

The single FOBT test did badly, with a sensitivity of only 4.9% in detecting "advanced neoplasia" which was defined as tubular adenomas larger than 10 mm., adenomas with villous patterns, high grade dysplasia or invasive cancer. The six test kit did better with a sensitivity of 23.9%.

Specificities for the two tests were in the 90% plus range. The authors concluded that the single finger FOBT is a poor screening test and clearly it is not enough to do if the intent is screening for colon cancer or polyps. I would add that the six-sample method is certainly not a substitute for colonoscopy either.

More on Quality Improvement Organizations"-another study fails to clearly show they work

I have written before the Quality Improvement Organizations (QICs) .The Sept 5, issue of the Annals of Internal Medicine published another study that was unable to clearly demonstrate that their efforts to improve quality in fact improves quality. The accompanying editorial noted that although the study tended to show some rather small improvements in the group that received a quality improvement "intervention", other factors not adequately controlled for could also have been responsible study design and analysis left much to desire. The editorialist quotes a 2006 publication for the Institute of Medicine that noted of 33 recent studies investigating QICs efficacy 9 show positive results, 16 yielded ambiguous results and 8 either found no impact or a negative impact .

Allthough the QIC website proclaims the organization strives to "make sure patients get the right care at the right time" studies-including their own such as this one from the Annals- seem unable to unambiguously demonstrate that what they do improve quality and even when some indication of quality improves (and in the interest of fairness it should be noted that a number of indicators did show improvement) after intervention the studies are so poorly designed they cannot attribute the results to their efforts.

I can't decide if their statement "make sure patients get the right care at the right time" is born of extreme naivete or typical governmental bureaucratic hubris but I think that any physician who has been in practice for more than five minutes would never promise anything so grandiose and impossible to deliver.The QICs seem unable to do something much simpler,namely to show that their interventions actually do what they purport to do but do not loose faith, the authors promise us more and better designed studies.

Trial underway to test use of steroids in severe pneumonia

In the August 14,2006 issue of Internal Medicine News we learn of reports that corticosteroids may reduce the morbidity and mortality of severe bacterial pneumonia.

Dr. Antoni Torres from the University of Barcelona apparently become interested in the potential value of steroids in this application from his observational study of 1,424 hospitalized patients in which one of the independent protective risk factors was COPD. This seems counterintuitive but he reasoned that perhaps it was the use of steroids (which is routine in exacerbations of COPD) that was protective.

The news article reported that a small RCT (46 patients) showed a reduction in mortality in the group receiving 200 mg of hydrocortisome IV followed by 7 days of a lower dose(Am J. Respir.Crit.Care.2005,171:242-8). I could not find that reference on PUBMED but here Dr. Torres discusses the issue.

Another larger RCT is currently in progress in Italy. Patients will be those with community acquired pneumonia who have a high mortality risk and a C-reactive-protein above 15. The thought here seems to be that in severe pneumonia -as flagged by the CRP value-there is an important element of systemic inflammatory response which might be mitigated by the steroids.

The value of steroids in sepsis has been difficult to ascertain as indicated in this 2004 Annals of Internal Medicine summary of a recent meta-analysis. I suspect the value of steroids may be a bit hard to sort out in pneumonia as well. RCTs in seriously ill patients who are heterogeneous in multiple aspects offer quite a challenge and finding the right dose-if there is one-may be difficult as suggested by the results of the sepsis treatment meta-analysis in which it appeared that "high-dose" was harmful and "low dose" helpful.